Innova Medical Group, Inc. FDA Recalls

3 recalls on file across devices, 3 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
COVID-19 Self-Test Kit * INNOVA * 3TClass IApr 9, 2021Due to distributing test kits to customers who were not part	Due to distributing test kits to customers who were not part of a clinical investigation.	Class IDevices	Apr 9, 2021
For In Vitro Diagnostic Use Only * 25T 888 SARS-CoV-2 Antigen * SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BTClass IApr 9, 2021Due to distributing test kits to customers who were not part	Due to distributing test kits to customers who were not part of a clinical investigation.	Class IDevices	Apr 9, 2021
COVID-19 Self-Test Kit * INNOVA * 7TClass IApr 9, 2021Due to distributing test kits to customers who were not part	Due to distributing test kits to customers who were not part of a clinical investigation.	Class IDevices	Apr 9, 2021